PMID- 31094331 OWN - NLM STAT- MEDLINE DCOM- 20200214 LR - 20230502 IS - 1438-8871 (Electronic) IS - 1439-4456 (Print) IS - 1438-8871 (Linking) VI - 21 IP - 5 DP - 2019 May 13 TI - Reducing Stress and Preventing Depression (RESPOND): Randomized Controlled Trial of Web-Based Rumination-Focused Cognitive Behavioral Therapy for High-Ruminating University Students. PG - e11349 LID - 10.2196/11349 [doi] LID - e11349 AB - BACKGROUND: Prevention of depression is a priority to reduce its global disease burden. Targeting specific risk factors, such as rumination, may improve prevention. Rumination-focused Cognitive Behavioral Therapy (RFCBT) was developed to specifically target depressive rumination. OBJECTIVE: The primary objective of this study was to test whether guided Web-based RFCBT (i-RFCBT) would prevent the incidence of major depression relative to usual care in UK university students. The secondary objective was to test the feasibility and estimated effect sizes of unguided i-RFCBT. METHODS: To address the primary objective, a phase III randomized controlled trial was designed and powered to compare high risk university students (N=235), selected with elevated worry/rumination, recruited via an open access website in response to circulars within universities and internet advertisements, randomized to receive either guided i-RFCBT (interactive Web-based RFCBT, supported by asynchronous written Web-based support from qualified therapists) or usual care control. To address the secondary objective, participants were also randomized to an adjunct arm of unguided (self-administered) i-RFCBT. The primary outcome was the onset of a major depressive episode over 15 months, assessed with structured diagnostic interviews at 3 (postintervention), 6, and 15 months post randomization, conducted by telephone, blind to the condition. Secondary outcomes of symptoms of depression and anxiety and levels of worry and rumination were self-assessed through questionnaires at baseline and the same follow-up intervals. RESULTS: Participants were randomized to guided i-RFCBT (n=82), unguided i-RFCBT (n=76), or usual care (n=77). Guided i-RFCBT reduced the risk of depression by 34% relative to usual care (hazard ratio [HR] 0.66, 95% CI 0.35 to 1.25; P=.20). Participants with higher levels of baseline stress benefited most from the intervention (HR 0.43, 95% CI 0.21 to 0.87; P=.02). Significant improvements in rumination, worry, and depressive symptoms were found in the short-to-medium term. Of the 6 modules, guided participants completed a mean of 3.46 modules (SD 2.25), with 46% (38/82) being compliant (completing >/=4 modules). Similar effect sizes and compliance rates were found for unguided i-RFCBT. CONCLUSIONS: Guided i-RFCBT can reduce the onset of depression in high-risk young people reporting high levels of worry/rumination and stress. The feasibility study argues for formally testing unguided i-RFCBT for prevention: if the observed effect sizes are robustly replicated in a phase III trial, it has potential as a scalable prevention intervention. TRIAL REGISTRATION: ISRCTN Registry ISRCTN12683436; https://www.isrctn.com/ISRCTN12683436 (Archived by WebCite at http://www.webcitation.org/77fqycyBX). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s13063-015-1128-9. CI - (c)Lorna Cook, Mohammod Mostazir, Edward Watkins. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 13.05.2019. FAU - Cook, Lorna AU - Cook L AUID- ORCID: 0000-0002-1958-8583 AD - SMART Lab, Mood Disorders Centre, School of Psychology, University of Exeter, Exeter, United Kingdom. FAU - Mostazir, Mohammod AU - Mostazir M AUID- ORCID: 0000-0002-8657-515X AD - College of Life and Environmental Sciences (CLES), School of Psychology, University of Exeter, Exeter, United Kingdom. FAU - Watkins, Edward AU - Watkins E AUID- ORCID: 0000-0002-2432-5577 AD - SMART Lab, Mood Disorders Centre, School of Psychology, University of Exeter, Exeter, United Kingdom. LA - eng GR - WT_/Wellcome Trust/United Kingdom PT - Clinical Trial, Phase III PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20190513 PL - Canada TA - J Med Internet Res JT - Journal of medical Internet research JID - 100959882 SB - IM MH - Adolescent MH - Adult MH - Cognitive Behavioral Therapy/*methods MH - Depression/*prevention & control/*therapy MH - Female MH - Humans MH - Internet MH - Male MH - Rumination, Cognitive/*physiology MH - Students MH - Universities MH - Young Adult PMC - PMC6536298 OTO - NOTNLM OT - cognitive behavioral therapy OT - depression OT - prevention OT - rumination, cognitive OT - stress, psychological OT - student health services COIS- Conflicts of Interest: EW developed the original RFCBT intervention. The other authors declare they have no competing interests. EDAT- 2019/05/17 06:00 MHDA- 2020/02/15 06:00 PMCR- 2019/05/13 CRDT- 2019/05/17 06:00 PHST- 2018/06/22 00:00 [received] PHST- 2019/03/24 00:00 [accepted] PHST- 2019/03/15 00:00 [revised] PHST- 2019/05/17 06:00 [entrez] PHST- 2019/05/17 06:00 [pubmed] PHST- 2020/02/15 06:00 [medline] PHST- 2019/05/13 00:00 [pmc-release] AID - v21i5e11349 [pii] AID - 10.2196/11349 [doi] PST - epublish SO - J Med Internet Res. 2019 May 13;21(5):e11349. doi: 10.2196/11349.